Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
146
Countries
4
Sites
13
Classical Hodgkin Lymphoma
To evaluate complete response (CR) rate at the end of study intervention in participants with newly diagnosed classical Hodgkin Lymphoma (cHL) assessed by independent central review according to Lugano 2014 response criteria
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 8 Nov 2021 → 26 May 2024
- Decision date (initial)
- 2023-08-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2022-501615-14-00
- EudraCT number
- 2021-001244-95
- WHO UTN
- U1111-1281-5347
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenetic, Safety, Therapy, Pharmacogenomic, Pharmacoeconomic, Efficacy
To evaluate complete response (CR) rate at the end of study intervention in participants with newly diagnosed classical Hodgkin Lymphoma (cHL) assessed by independent central review according to Lugano 2014 response criteria
Secondary objectives 5
- To evaluate the CR rate at the end of study intervention in participants with newly diagnosed cHL by investigator assessment according to Lugano 2014 response criteria
- To evaluate the duration of complete response (DurCR) in participants with newly diagnosed cHL by independent central review according to Lugano 2014 response criteria
- To evaluate the rate of Positron Emission Tomography (PET) negativity at PET2 following 3 cycles of pembrolizumab monotherapy by independent central review according to the 2-flurodeoxyglucose (FDG)-PET 5-point scale
- To evaluate the rate of PET negativity at PET3 after completion of 3 cycles of pembrolizumab monotherapy followed by 2 cycles of doxorubicin in combination with vinblastine and dacarbazine (AVD) by independent central review according to the FDG-PET 5-point scale
- To evaluate the safety and tolerability of initial pembrolizumab monotherapy followed by chemotherapy and pembrolizumab consolidation in participants with newly diagnosed cHL
Conditions and MedDRA coding
Classical Hodgkin Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10080208 | Classical Hodgkin lymphoma | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
- Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
- Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
- Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention
Exclusion criteria 12
- Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)
- Has an uncontrolled intercurrent cardiovascular illness
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
- Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
- Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has a history or current evidence of pulmonary fibrosis
- Has had an allogenic tissue/solid organ transplant
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Complete Response (CR) at the End of Study Intervention as Assessed by Independent Central Review Per Lugano 2014 Response Criteria
Secondary endpoints 6
- CR at the End of Study Intervention as Assessed by Investigator Per Lugano 2014 Response Criteria
- Duration of Complete Response (DurCR) as Assessed by Independent Central Review Per Lugano 2014 Response Criteria
- Positron Emission Tomography (PET) Negativity by Independent Central Review Per 2-Fluorodeoxyglucose (FDG)-PET 5-point Scale After Administration of Pembrolizumab Monotherapy
- PET Negativity by Independent Central Review Per FDG-PET 5-point Scale After Administration of Pembrolizumab Monotherapy and Chemotherapy
- Number of Participants Who Experienced an Adverse Event (AE)
- Number of Participants Who Discontinued Study Treatment Due to an AE
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
SCP4290181 · ATC
- Active substance
- Dacarbazine
- Substance synonyms
- DIC, DACARBAZINUM
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 4500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AX04 — DACARBAZINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Substance synonyms
- Lambrolizumab, MK-3475, SCH-900475, ABP 234
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 1400 mg milligram(s)
- Max treatment duration
- 33 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6155697 · ATC
- Active substance
- Etoposide
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1600 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP132446 · ATC
- Active substance
- Prednisolone
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Route of administration
- ORAL
- Max daily dose
- 40 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2240 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP4338931 · ATC
- Active substance
- Vinblastine Sulfate
- Substance synonyms
- VINBLASTINE SULPHATE
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 2 mg/m2 milligram(s)/sq. meter
- Max total dose
- 8 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CA02 — VINCRISTINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1728208 · ATC
- Active substance
- Anhydrous Cyclophosphamide
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1250 mg/m2 milligram(s)/sq. meter
- Max total dose
- 5000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP6096904 · ATC
- Route of administration
- ORAL
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XB01 — PROCARBAZINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP6822176 · ATC
- Active substance
- Vinblastine Sulfate
- Substance synonyms
- VINBLASTINE SULPHATE
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 6 mg/m2 milligram(s)/sq. meter
- Max total dose
- 72 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CA01 — VINBLASTINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1712543 · ATC
- Active substance
- Doxorubicin
- Substance synonyms
- ADRIAMYCIN
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 35 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP7563781 · ATC
- Active substance
- Bleomycin
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 10 IU international unit(s)
- Max total dose
- 40 IU international unit(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DC01 — BLEOMYCIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Akash Nahar
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Akash Nahar
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | E-data capture |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Signant Health Global LLC ORG-100040604
|
San Francisco, United States | Interactive response technologies (IRT) |
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Livingston, United Kingdom | Laboratory analysis |
Locations
4 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 10 | 5 |
| Italy | Ended | 18 | 4 |
| Poland | Ended | 8 | 2 |
| Spain | Ended | 14 | 2 |
| Rest of world
Turkey, United States, Australia, Canada, Israel, Russian Federation, Chile
|
— | 96 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
Service d'Hématologie clinique et Thérapie cellulaire, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Rennes
Service d'Hematologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Hospices Civils De Lyon
Service d'Hematologie, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Henri Becquerel
Service d'Hématologie, 1 Rue D Amiens, 76000, Rouen
Centre Hospitalier Universitaire De Dijon
Service d'Hematologie, 14 Rue Paul Gaffarel, 21000, Dijon
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UO Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UO Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento ematologia ed oncologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Ematologia e Trapianto di cellule staminali emopoietiche, Largo Francesco Vito 1, 00168, Rome
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii I Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba S/n, Madrid
Institut Catala D'oncologia
Hematology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2022-04-13 | 2024-05-22 | 2022-04-13 | 2022-06-15 | |
| Italy | 2022-02-16 | 2024-05-21 | 2022-02-24 | 2022-06-15 | |
| Poland | 2022-03-14 | 2024-05-20 | 2022-04-12 | 2022-06-15 | |
| Spain | 2021-11-08 | 2024-05-21 | 2021-11-09 | 2022-06-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results for Final Analysis SUM-83387
|
2025-05-21T09:49:37 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| RPLS_2022-501615-14_for pub | 2025-05-21T09:50:48 | Submitted | Laypersons Summary of Results |
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | RPLS_2022-501615-14_ESP_ES_for pub | 16APR2025 |
| Laypersons summary of results (for publication) | RPLS_2022-501615-14_for pub | 16APR2025 |
| Laypersons summary of results (for publication) | RPLS_2022-501615-14_FRA_FR_for pub | 16APR2025 |
| Laypersons summary of results (for publication) | RPLS_2022-501615-14_ITA_IT_for pub | 16APR2025 |
| Laypersons summary of results (for publication) | RPLS_2022-501615-14_POL_PL_for pub | 16APR2025 |
| Summary of results (for publication) | Summary of results for Final Analysis_2022-501615-14_for pub | 12MAY2025 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-16 | France | Acceptable 2023-08-25
|
2023-08-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-01-18 | France | Acceptable 2024-03-25
|
2024-03-27 |